Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2025-12-24 @ 2:48 PM
NCT ID:
NCT07238959
Eligibility Criteria:
Inclusion Criteria:
1. Male, aged 18-80 years;
2. PSA \> 4 ng/ml;
3. Patients meeting criteria for prostate biopsy:
* fPSA/PSA \< 0.16 or PSA D \> 0.15 or PSA V \> 0.75; ② Positive digital rectal examination (DRE); ③ Imaging studies (ultrasound/MRI) showing suspicious lesions.
Exclusion Criteria:
1. Patients diagnosed with any malignant tumour within the past five years;
2. Patients who have undergone transurethral resection or enucleation of the prostate;
3. Patients who have previously received treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, or immunotherapy;
4. Patients on long-term anticoagulant or antiplatelet therapy (anticoagulants discontinued for less than one week);
5. Patients who have received any form of tumour treatment prior to enrolment blood sampling, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy, or immunotherapy;
6. Concurrent severe systemic diseases deemed by the investigator likely to interfere with trial treatment, evaluation, or compliance, including serious respiratory, circulatory, neurological, psychiatric, gastrointestinal, endocrine, immunological, or urological disorders;
7. Organ transplant recipients or individuals with prior non-autologous (allogeneic) bone marrow or stem cell transplantation;
8. Subjects who have undergone blood transfusion within one month prior to blood sampling;
9. Patients currently participating in other clinical trials, or who have participated in other clinical trials within the past year;
10. Patients deemed unsuitable for this clinical trial by the investigator;
11. Patients meeting any of the above criteria shall not be eligible for inclusion as subjects.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07238959
Study Brief:
Protocol Section:
NCT07238959